Kornimate/medical-research-clean huggingface dataset:
study of treximet, formerly known as trexima, in the acute treatment of multiple migraine attacks

Conditions: Migraine Disorders

Summary: the purpose of this study is to determine the consistency of response for treximet (formerly known as trexima) when treating four acute migraine attacks at the mild pain phase and within 1 hour of onset of head pain.


Eligibility criteria:
inclusion criteria: * at least a 6 month history of physician diagnosed migraine and typically experiences 2-6 migraine attacks per month. * typically experiences moderate to severe migraine pain preceded by a mild pain phase. * differentiate between mild migraine pain and other headache types. * women of childbearing potential must be on adequate contraception. exclusion criteria: * pregnant and/or nursing mother. * history of cardiovascular disease. * uncontrolled hypertension. * basilar or hemiplegic migraine. * history of stroke or transient ischemic attacks (tia). * history of epilepsy or treated with anti-epileptics within past 5 years. * impaired hepatic or renal function. * history of gastrointestinal bleeding or ulceration. * allergy or hypersensitivity to aspirin or any other nsaid. * allergy or hypersensitivity to triptans. * participated in an investigational drug trial in the previous 4 weeks.

Keywords: consistency of response migraine satisfaction early intervention
a retrospective study of real world treatment outcomes of patients with chronic hepatitis c

Conditions: Hepatitis C, Chronic

Summary: this retrospective, observational study will assess the real world treatment out comes in the management of patients with chronic hepatitis c. no prospective ass essment or procedure with patients during this study will be conducted. data wil l be collected from patient medical records of the year 2000-2011.


Eligibility criteria:
inclusion criteria: * patients newly diagnosed with chronic hepatitis c during the year 2000 to 2010 * availability of data for at least 6 months following the diagnosis date exclusion criteria: * patients who participated in an investigational clinical trial * co-infection with hepatitis a, hepatitis b, hepatitis d, and/or human immunodeficiency virus (hiv) * patients with known severe medical conditions that are contraindicated to hcv treatment
computerized psychoeducation for anxiety sensitivity

Conditions: Anxiety Sensitivity

Summary: this investigation examines the efficacy of a 35 minute computerized psychoeducation protocol in the reduction of elevated anxiety sensitivity cognitive concerns, a risk factor for the development and maintenance of various forms of psychopathology.


Eligibility criteria:
inclusion criteria: * elevated anxiety sensitivity cognitive concerns and indicated by the anxiety sensitivity index-3 exclusion criteria: * history of epilepsy or seizures
improving mental health in diabetes: a guided self-help study

Conditions: Type 2 Diabetes; Anxiety; Depression

Summary: this study employs a randomised controlled trial design to investigate whether a cbt-based guided self-help intervention can improve anxiety, depression, psychological well-being, quality of life, diabetic self-care and adherence; as compared to controls. the study aims to recruit 42 individuals with diabetes and mild to moderate anxiety or depression. anxiety and depression are common in patients with type 2 diabetes, and has been shown to affect diabetes control. literature suggests that cbt can benefit individuals with diabetes and comorbid mental ill-health, however little research has been done to date on the effect of guided self-help in this population. it is expected that this intervention will improve patient's mental health, as well as extend the limited knowledge-base on guided self-help in chronic illness.


Eligibility criteria:
inclusion criteria: * individuals with a diagnosis of type 2 diabetes with mild-moderate anxiety and/or depression (scoring 8 to 15 on the hads scale) will be recruited, provided they do not meet any one of the exclusion criteria listed below. patients will be able to provide written informed consent. exclusion criteria: * individuals with a history of clinically diagnosed psychotic symptoms, schizophrenia or bipolar disorder. * participants with a known learning disability or severe visual impairment. * participants who cannot read or write * participants under 18 years of age or over age 75 * long-term hospital inpatients * individuals with a diagnosis of diabetes secondary to a major physical condition (consultation will be sought from medical professionals where appropriate on an individual basis)
necrotizing soft tissue infections and their scoring system

Conditions: Necrosis

Summary: primary objective: the primary objective of this study is to develop and validate a clinical risk index score for identifying nstis in emergency general surgery patients being evaluated for a severe skin and soft tissue infection. secondary objectives: to describe the contemporary microbiology of nstis and explore the effects on outcomes and to identify predictors of amputation and mortality.

this study is designed as a multicenter, prospective, observational study. there will be no direct interaction with subjects and involves no interventions; study is conducted completely via review of electronic health records. our site will only collect data from the methodist dallas medical center. we plan to complete the data collection and analysis by 12/30/2021.

Eligibility criteria:
inclusion criteria: * all adult patients (age ≥18 years old and ≤89 years old) with suspected or confirmed nsti exclusion criteria: * age \ 89 years * pregnancy * prisoners * below ankle diabetic foot infections complicated by peripheral vascular disease * burn wounds
metoprolol in acute respiratory distress syndrome (maiden)

Conditions: Acute Respiratory Distress Syndrome (ARDS)

Summary: randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy of intravenous metoprolol in patients with acute respiratory respiratory distress syndrome (ards).

this is a placebo-controlled, randomised, double-blind, multicentre, phase iii clinical trial to assess the efficacy of iv metoprolol in newly intubated ards patients, assessing survival and days free of invasive mechanical ventilation during the first 28 days. eligible participants shall have had orotracheal intubation (oti) and mechanical ventilation within 72 hours prior to randomisation, moderate-severe ards (pao2/fio2: ≤200 mmhg under standardised conditions (peep≥5 cm h2o), a heart rate ≥ 60 bpm and invasive systolic blood pressure ≥ 110 mmhg.the trial will include a total of n=350 patients, with two treatment arms: metoprolol vs. placebo (1:1). each of the 7 days of treatment, participants will be receive 15 mg of iv metoprolol tartrate or matching placebo in 100 ml of saline for 10 minutes.

Eligibility criteria:
inclusion criteria: * patients (≥18 years and \<80 years) with a clinical diagnosis of ards of any aetiology (pneumonia, including sars-cov-2, sepsis, pancreatitis, bronchospasm and trauma) admitted to the icu. * orotracheal intubation (oti) and mechanical ventilation within 72 hours prior to randomisation. * moderate-severe ards (pao2/fio2: ≤200 mmhg under standardised conditions (peep≥5 cm h2o). * heart rate ≥ 60 bpm. * invasive systolic blood pressure ≥ 110 mmhg. exclusion criteria: * prolonged hospital admission prior to randomisation (i.e. ≥7 days at the time of randomisation). * reduced left ventricular ejection fraction (lvef \<50%). * life expectancy due to other processes (cancer, degenerative diseases, etc.) of less than 6 months. * right ventricular (rv) systolic dysfunction. * concomitant acute heart failure (cardiac index ≤2.5 l/m2 or pulmonary capillary pressure ≥15 mmhg or clinical suspicion). * second-degree atrioventricular (av) block, 2:1 av block, high-grade/advanced av block and third-degree av block. also significant sinus bradycardia, which would be implied by having a heart rate \>60 bpm as an inclusion criterion. * pregnant or breastfeeding women. * cardiogenic shock. * persistent invasive blood pressure \<110 mmhg despite vasopressor agents. * use of noradrenaline at concentrations greater than 0.2 µg/kg/min at the time of the randomisation. * use of dobutamine within 48 hours before randomisation. * concomitant pulmonary embolism. * known severe peripheral arterial disease. * known asthma before admission (with active bronchodilator therapy). * active beta-blocker treatment prior to admission (i.e. within 3 months prior to admission).

Keywords: metoprolol beta-blockers sepsis orotracheal intubation pathologic processes respiratory disease neutrophil extracellular traps platelet aggregation diffuse alveolar damage neutrophil infiltration pulmonary inflammation pancreatitis severe acute respiratory syndrome-corona virus-2 drug-related side effects and adverse reactions
thoracic drains in intensive care units: comparison of seldinger and surgical methods

Conditions: Pleural Effusion; Pneumothorax; Hemothorax

Summary: this prospective randomized multicenter study is intended to investigate tolerance and effectiveness of thoracic drainage conducted by seldinger technique with small drains, or by a surgical-like technique with large armed drains, in intensive care units patients.

drainage of pleural effusion and pneumothorax is a common feature in resuscitation, intensive care units (icu) and continuing care units (ccu). although they are associated with a low incidence of complications (ranging from 0 to 8%), some of these can become fatal if they are associated with a visceral puncture (liver, spleen, lung parenchyma or heart by instance). it has been reported in the literature that complications were greater in case of drainage with large diameter drains set up by so-called "surgical-like" technique. the choice of the type of chest tube is usually guided by the indication of drainage or the habits and / or experience of the practitioner. in the case of liquid pleural effusions, it may be preferable to use small diameter drains, whereas in the case of suspicious thick effusions such as empyema or blood, it may be preferable to use drainage drains of a larger diameter. however, results of retrospective analyzes seem to suggest the versatile and effective use of small-bore chest tubes in any of these indications without increasing complications' rates such as clogging. however, no prospective randomized controlled trial (rct) has studied this issue to date. therefore, the investigators propose to perform a multicenter rct in icu and ccu patients requiring pleural drainage for any indication or underlying disease. this prospective rct is intended to investigate tolerance and effectiveness of thoracic drainage conducted by seldinger technique with small drains, or by a surgical-like technique with large armed drains. furthermore, they want to estimate the respective costs, identify the difficulties related to both strategies, recognize associated practices (ultrasound-guidance, implantation site, operator's competence), and finally point out the secondary determinants of tolerance and effectiveness.

Eligibility criteria:
inclusion criteria: * of-age patient (\>18years) * patient admitted in icu or ccu * patient requiring a pleural drainage, semi-urgent or planned * patient with a social security insurance exclusion criteria: * patient under guardianship * severe or uncompensated bleeding disorders * thoracic trauma at the acute phase (\<6 hours) * compressive pneumothorax requiring immediate and urgent needle exsufflation * no thoracic drainage (whatever the technique used) performed previously during the same stay in icu or ccu.

Keywords: pleural effusion pneumothorax hemothorax intensive care unit seldinger drain chest drainage complications comparison of chest drainage techniques in icu patients small drain inserted by seldinger technique large drains inserted by surgical-like technique
modulation of cortical gamma synchrony in stroke

Conditions: Stroke

Summary: in the last decades, the research in neuroimaging-informed stroke prognosis and treatment has had a little clinical impact, often because of the costs of bringing complex procedures to the bedside. cerebral stroke remains the leading cause of disability, with 65% of survivors chronically impaired at 6 months. gamma synchrony (gs) is a fundamental mechanism of cortical function and can be estimated and modulated in a simple, inexpensive, and reliable way. it has provided valuable and cost-effective guidance in several neuropsychiatric conditions. in previous studies, we developed simple yet robust methods for assessing and manipulating gs and proved its relationship with clinical impairment in preliminary data. the aim of the present project is to predict and improve stroke recovery by leveraging cortical mapping and modulation of gs via transcranial alternating current stimulation (tacs), a safe and inexpensive technique. the project capitalizes on technology readily available to the italian national health system.

the project will consist of 3 work packages (wps): * the aim of wp1 is to map the relationship between gs and clinical outcomes with eeg. * the aim of wp2 is to translate gs assessment and modulation to bedside. * the aim of wp3 is to modulate gs to improve rehabilitation outcomes.

Eligibility criteria:
the participants in this study will be 140 stroke patients rehabilitated at irccs san camillo hospital. 80 will participate in the wp1 and the wp2, while 60 will participate in the wp3 study. in wp1, data will also be collected on 80 healthy volunteer participants, approximately the same age as the patients. inclusion criteria (healthy participants) - no neurological or psychiatric disorder inclusion criteria (patients) * right or left hemisphere damage * unilateral stroke * no comorbidities with psychiatric disorders exclusion criteria (general): * diagnosis of epilepsy or family history up to the second degree with it * episodes of febrile convulsions or recurrent fainting * head trauma * presence of surgical clips or metal implants in the head * diagnosis of heart disease * presence of a cardiac pacemaker or artificial heart valve * presence of hearing aids/prostheses * hearing problems or tinnitus * vision problems not corrected with lenses (such as color blindness) * taking tricyclic antidepressant medications * taking neuroleptic medications * diagnosis of headache or migraine

Keywords: tacs gamma synchrony
brainstem dysfunction involvement in the pathogenesis of pierre robin sequence

Conditions: Pierre Robin Sequence; Brainstem Dysfunction

Summary: introduction pierre robin sequence, prs, incidence is about one hundred births per year in france. the main neonatal clinical manifestations are secondary to airway obstruction and food difficulties related to swallowing disorders. despite recent progress, the pathogenesis of prs is not fully understood. the hypothesis is that brainstem dysfunction, bsd, plays a central role in the pathogenesis of prs. the purpose of the study is to achieve a complete evaluation of bsd to specify its role in the pathogenesis of prs. the primary objective is to compare central apnea index (cai) of infants with prs with those of infants with isolated airway obstruction (awo) and those of healthy infants in order to clarify the direct role of bsd. material and methods this prospective interventional study will be carried out in lyon at the hôpital femme-mère-enfant and in paris at the hôpital necker-enfants malades for 2 years. 3 groups of patients will be studied: prs, 50 patients, awo, 50 patients and healthy, 30 patients, included before 2 months of life. infants will be followed for a maximum of 10 months. the evaluations will be carried out for 48 hours between birth and 2 months of life and then for 24 hours between 6 and 10 months of life for prs and awo group. concerning the healthy group, the evaluation will be carried out during 48h during a single hospitalization before 2 months. polysomnography, holter-ecg, 24h gas exchange, impedance-ph monitoring and mental region eeg will be performed. the central apnea index (mean number per hour), obstructive apnea index, non-nutritive swallowing index (nns), gastroesophageal reflux and nns-respiration coordination will be assessed for each stage of sleep and compared between the three groups of patients.


Eligibility criteria:
inclusion criteria for the group 1 - infants with prs inclusion criteria for the group 2 - infant with isolated airway obstruction inclusion criteria for the group 3 - healthy infant : siblings of sudden unexpected death of the infant or with any known pathology inclusion criteria for the 3 groups * during one hospitalization or program for one hospitalization * parental consent * social safety affiliation exclusion criteria: * birth before 37 sa * neonatal complication * group 2 only: awo with neurological disease including brainstem dysfunction * group 3 only : awo, ent disease or syndromic disease, neurological disease including brainstem dysfunction, intra uterine growth retardation

Keywords: pierre robin sequence brainstem pathogenesis swallowing apnea
budesonide for emergency treatment of acute wheezing in children

Conditions: Asthma; Acute Asthma

Summary: the purpose of this study is to determine if adding nebulized budesonide to the systemic steroid for treatment of acute wheezing has any additive benefit in the emergency room.

context: inhaled steroids reduced admission rates in patients with acute asthma, but it is unclear if there is a benefit of inhaled corticosteroids when used in addition to systemic corticosteroids. there is insufficient evidence that inhaled corticosteroids result in clinically important changes in pulmonary function or clinical scores when used in acute asthma. similarly, it was mentioned in the cochrane database of systematic reviews that further research is needed to clarify if there is a benefit of inhaled corticosteroids when used in addition to systemic steroids. objective: to determine if adding nebulized budesonide to the systemic steroid for treatment of acute wheezing in the emergency room has any benefit on, symptom score, hospitalization rate and time to discharge from emergency room. study design/setting/participants: a double-blind, randomized, controlled trial of nebulized budesonide versus placebo for children 6 months to 6 years of age who have admitted to the emergency room for acute wheezing. intervention: participants will receive standard therapy including scs, albuterol, and ipratropium bromide and will be randomly assigned to also receive either nebulized bis or saline. study measures: differences in asthma scores, vital signs, and the need for hospitalization will be compared between treatment groups.

Eligibility criteria:
inclusion criteria: * children who have recurrent wheezing attacks and admitted to the emergency room for acute wheezing * pulmonary index score of 7-13 * parental/guardian permission (informed consent) and if appropriate, child assent exclusion criteria: * systemic corticosteroid use in the last 30 days * chronic lung diseases including cystic fibrosis * immunodeficiency * cardiac disease requiring surgery or medications * adverse drug reaction or allergy to budesonide, albuterol, ipratropium bromide, prednisone, prednisolone, or methylprednisolone * known renal or hepatic dysfunction * impending respiratory failure requiring positive pressure ventilation * immune deficiency * gastroesophageal reflux disease * suspected foreign body aspiration or croup * anatomic abnormalities of the respiratory tract

Keywords: wheezing acute asthma children budesonide emergency room
ha residents with pvd, sdb assessed at ha (2840m) vs la (sea level)

Conditions: Pulmonary Vascular Disease; Pulmonary Artery Hypertension; Chronic Thromboembolic Pulmonary Hypertension

Summary: to study the effect of relocation from 2840m (quito) to sea level (pedernales) in patients with pulmonary vascular diseases (pvd) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (ph) who permanently live \>2500m on sleep disordered breathing

this research in patients with pvd diagnosed with precapillary ph with right heart catheterization and classified to groups 1 and 4 (pah or cteph) who permanently live at ha \>2500 (pvdha) will have nocturnal respiratory sleep studies near their living altitude in quito at 2840m and at sea level in pedernales during the first and the second night after relocation.

Eligibility criteria:
inclusion criteria: * adult patients 18-80 years old of both genders, * residence \> 2500m of altitude * diagnosed with precapillary ph (mean pulmonary artery pressure (mpap) \>20 mmhg, pulmonary artery wedge pressure (pawp) ≤15 mmhg and pulmonary vascular resistance (pvr) ≥2 wu (wood units) by right heart catheterization) with ph being classified as pah or cteph according to guidelines * patients stable on therapy * nyha (new york heart association) functional class i-iii * provided written informed consent to participate in the study. exclusion criteria: * age \ 80 years * unstable condition * patients who cannot follow the study investigations, patient permanently living \< 2500m. * patients with moderate to severe concomitant lung disease (fev1\ 20 cigarettes/day) * severely hypoxemic patients at quito permanently have persistent spo2 (oxygen saturation by pulseoximetry) \<80% on ambient air. * patients with chronic mountain sickness (hemoglobin \> 19 g/dl in women, \>21 g/dl in men) * patient with a non-corrected ventricular septum defect * relevant concomitant other disease of the heart, kidney, liver, blood (anemia hemoglobin\<11 g/dl)

Keywords: pulmonary hypertension hypoxia sleep disordered breathing pulmonary arterial hypertension chronic thromboembolic pulmonary hypertension high altitude
efficacy and safety study of abatacept to treat lupus nephritis

Conditions: Lupus Nephritis

Summary: the purpose of this study is to evaluate (abatacept) for treatment of lupus nephritis when used on a background of cellcept (mycophenolate) and prednisone (corticosteroids)


Eligibility criteria:
for additional information please contact the bms lupus nephritis clinical trial matching service at 855-56-lupus. please visit www.bmsstudyconnect.com for more information on clinical trial participation. note: subjects \> 16 are eligible for enrollment at selected centers inclusion criteria: * potential subjects must have active lupus nephritis * biopsy within 12 months prior to screening visit indicating active class 3 or 4 proliferative lupus glomerulonephritis (lupus effecting your kidney) * urine protein creatinine ratio (upcr) ≥ 1 at screening * serum creatinine ≤ 3 mg/dl (ie, ≤ 265 micromol/l) * there must also be evidence of active disease within 3 months of screening, based on at least one of the following: * worsening of lupus nephritis or * upcr ≥ 3 at screening or * active urine sediment or * biopsy within 3 months prior to screening visit indicating active class 3 or class 4 active proliferative lupus glomerulonephritis inclusion criteria for the long-term extension period: * signed written informed consent * subjects who achieve a complete or partial renal response after completing 2 years of double-blind treatment exclusion criteria: * systemic lupus erythematosus (sle) must be the primary/main autoimmune diagnosis * current symptoms of severe, progressive, or uncontrolled non-sle related renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease, or other concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study * significant active central nervous system (cns) lupus with the exception of fatigue or mild stable cognitive * subjects who are diagnosed as end-stage renal disease or whose kidney damage is too significant and irreversible